BONA-BITE Air

GUDID 05206569001235

Addition curing silicone bite registration material

DMP DENTAL INDUSTRY S.A.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material
Primary Device ID05206569001235
NIH Device Record Key9e5b132f-7a33-4374-8075-33612c1182ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONA-BITE Air
Version Model NumberFast Set, 50ml
Company DUNS728534814
Company NameDMP DENTAL INDUSTRY S.A.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105206569001228 [Primary]
GS105206569001235 [Package]
Contains: 05206569001228
Package: Box [2 Units]
In Commercial Distribution
GS105206569001242 [Package]
Contains: 05206569001228
Package: Box [4 Units]
In Commercial Distribution
GS105206569001464 [Package]
Contains: 05206569001228
Package: Box [32 Units]
In Commercial Distribution
GS105206569002072 [Package]
Contains: 05206569001228
Package: Box starter pack [2 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-03
Device Publish Date2020-07-24

On-Brand Devices [BONA-BITE Air]

05206569000054Addition curing silicone bite registration material
05206569000047Addition curing silicone bite registration material
05206569001235Addition curing silicone bite registration material

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